BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131496 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14588
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    October 1, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S RIGHT VENTRICULAR (RV) LEAD AND PACEMAKER TRIGGERED A LEAD IMPEDANCE SAFETY SWITCH FOR A HIGH PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS. ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT THE PATIENT¿S SYSTEM WAS REPROGRAMMED TO UNIPOLAR PACE AND SENSE AND THAT THE PATIENT WILL CONTINUE TO BE MONITORED. ALL PRODUCTS REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS LATER PERFORMED AND THE RV LEAD WAS ABANDONED DUE TO A CONTINUATION OF HIGH PACING IMPEDANCES. THE PACEMAKER WAS ALSO EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611380 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4471| 4470| S606| 1298